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eLibrary > AAMI TIR44:2012 - Technical Information Report Non-invasive blood pressure motion artifact - Testing and evaluation of NIBP device performance in the presence of motion artifact >

AAMI TIR44:2012 - Technical Information Report Non-invasive blood pressure motion artifact - Testing and evaluation of NIBP device performance in the presence of motion artifact, 2012

AAMI TIR44:2012, Non-invasive blood pressure motion artifact - Testing and evaluation of NIBP device performance in the presence of motion artifact
Title page
AAMI Technical Information Report
Copyright information
Contents
Glossary of equivalent standards
Committee representation
Acknowledgment
Foreword
Introduction
1 Scope [Go to Page]
1.1 General
1.2 Exclusions
2 Normative references
3 Terms and definitions
4 Sources of Artifact Noise [Go to Page]
4.1 Patient induced
4.2 Patient ambulation
4.3 Transport
4.4 Physiologic artifact
4.5 Summary
5 Effect of Artifact on NIBP readings [Go to Page]
5.1 Summary of literature [Go to Page]
5.1.1 Simulation and Testing
5.1.2 Transport
5.1.3 Exercise Testing
5.1.4 Ambulatory Blood Pressure Monitoring (ABPM)
5.2 Magnitude of common artifact
5.3 Spectral content of common artifact
5.4 Examples of common artifact [Go to Page]
5.4.1 Arm reposition
5.4.2 Tremor
5.4.3 Transport (Helicopter)
5.4.4 Transport (Ground Ambulance)
6 Relevance of existing standards and protocols [Go to Page]
6.1 ANSI/AAMI SP10:2008, superseded by ANSI/AAMI/ISO 81060-2:2009
6.2 CEN/EN 1060-4
6.3 ANSI/AAMI ES60601-1:2005, A1:2012
6.4 ANSI/AAMI/IEC 80601-2-30:2009
6.5 ANSI/AAMI/ISO 81060-2:2009
6.6 BHS protocol for the evaluation of blood pressure measurement devices
6.7 Summary of existing standards
7 Working group scope and goals [Go to Page]
7.1 WG Scope
7.2 General Goals
8 Motion artifact performance evaluation methods [Go to Page]
8.1 Challenges [Go to Page]
8.1.1 Reference Readings
8.1.2 Blood pressure variation
8.1.3 Test Repeatability
8.1.4 Test subject mobility
8.1.5 Proprietary Systems
8.2 General concepts for motion artifact evaluation [Go to Page]
8.2.1 SP10 baseline plus noise approach
8.2.2 Case-specific test approach
8.3 Implementation into NIBP standards [Go to Page]
8.3.1 Required minimum level of artifact tolerance for intended use
8.3.2 Voluntary “motion tolerant” labeling
8.3.3 Rankings or levels of motion tolerance
8.4 Test methods [Go to Page]
8.4.1 Simulator vs Clinical Protocol
8.5 Intended use focused recommendations (preliminary) [Go to Page]
8.5.1 Stress testing [Go to Page]
8.5.1.1 General Approach
8.5.1.2 Types of artifact noise in scope
8.5.1.3 Testing Protocol
8.5.1.4 Reporting of Results
8.5.1.5 Open Issues
8.5.2 Transport [Go to Page]
8.5.2.1 General Approach
8.5.2.2 Types of artifact noise in scope
8.5.2.3 Testing Protocol
8.5.2.4 Reporting of Results
8.5.2.5 Open Issues
8.5.3 Patient Ambulation (ABPM) [Go to Page]
8.5.3.1 General Approach
8.5.3.2 Types of artifact noise in scope
8.5.3.3 Testing Protocol
8.5.3.4 Reporting of Results
8.5.3.5 Open Issues
8.6 Whole body vibration
9 Working Group recommendations and next steps
10 References [Go to Page]

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